Table 2.

Treatment-emergent AEs

AEsAll treated patients (n = 159), n (%)
Any gradeGrade 3/4
Most common AEs*   
 Diarrhea 99 (62) 5 (3) 
 Nausea 68 (43) 2 (1) 
 Neutropenia 66 (42) 52 (33) 
 Arthralgia 53 (33) 2 (1) 
 Hypertension 25 (16) 9 (6) 
 Neutrophil count decreased 16 (10) 8 (5) 
Other AEs of clinical interest   
 Atrial fibrillation 7 (4) 2 (1) 
 Major hemorrhage 3 (2) 2 (1) 
Laboratory safety parameters   
 Hematology   
  Neutrophils decreased 115 (72) 60 (38) 
  Platelets decreased 94 (59) 20 (13) 
  Hemoglobin decreased 31 (19) 
 Chemistry   
  Corrected calcium decreased 61 (38) 1 (1) 
  Potassium increased 39 (25) 4 (3) 
  Uric acid increased 34 (21) 34 (21) 
  Creatinine increased 27 (17) 
AEsAll treated patients (n = 159), n (%)
Any gradeGrade 3/4
Most common AEs*   
 Diarrhea 99 (62) 5 (3) 
 Nausea 68 (43) 2 (1) 
 Neutropenia 66 (42) 52 (33) 
 Arthralgia 53 (33) 2 (1) 
 Hypertension 25 (16) 9 (6) 
 Neutrophil count decreased 16 (10) 8 (5) 
Other AEs of clinical interest   
 Atrial fibrillation 7 (4) 2 (1) 
 Major hemorrhage 3 (2) 2 (1) 
Laboratory safety parameters   
 Hematology   
  Neutrophils decreased 115 (72) 60 (38) 
  Platelets decreased 94 (59) 20 (13) 
  Hemoglobin decreased 31 (19) 
 Chemistry   
  Corrected calcium decreased 61 (38) 1 (1) 
  Potassium increased 39 (25) 4 (3) 
  Uric acid increased 34 (21) 34 (21) 
  Creatinine increased 27 (17) 
*

AEs of any grade occurring in ≥30% of patients or grade 3/4 occurring in ≥5% of patients.

Major hemorrhage was identified using the Standardized MedDRA Query for Hemorrhage, excluding laboratory terms.

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